Justify proposed dosage and high strength with data: CDSCO Panel Tells Hetero Healthcare on Tioconazole vaginal film 300 mg

New Delhi: Noting Tioconazole Vaginal Film 300mg is not approved anywhere in the world, the Subject Expert Committee SEC functional under the Central Drug Standard Control Organisation (CDSCO) has opined Hetero Healthcare to submit adequate rational/justification for the development of the proposed dosage form in such high strength along with release pattern data of the proposed formulation, adequate toxicity data, anticipated side effects, and supportive clinical evidence of the proposed dosage form to CDSCO for further review by the committee.

This came after Hetero Healthcare presented the proposal for manufacturing and marketing of Tioconazole Vaginal Film 300 mg along with Phase III protocol (Protocol No. HHCL/01-01/24 version 1.0 dated 18/01/2024) before the committee.

The committee noted that Tioconazole Vaginal Film 300mg is not approved anywhere in the world. However, Ticonazole vaginal gel 65mg/gm is approved in India on dated 22.03.2011. However, Ticonazole vaginal gel 65mg/gm is approved in India on dated 22.03.2011.

The committee further noted that the justification for using the reference drug, Canesten V6 (Clotrimazole) vaginal tablet 100 mg, is not adequate when the dosage form of Ticonazole is available.

In addition to the above, the committee also mentioned that the applied dose is 5-fold higher than the approved dose (Ticonazole vaginal gel 65 mg/g). The committee urged that preclinical data and vaginal toxicity data should support such a higher dose.

Tioconazole is an imidazole antifungal used to treat fungal and yeast infections. Topical formulations are used for ringworm, jock itch, athlete's foot, and tinea versicolor or "sun fungus". Tioconazole interacts with 14-alpha demethylase, a cytochrome P-450 enzyme that converts lanosterol to ergosterol, an essential component of the yeast membrane. In this way, tioconazole inhibits ergosterol synthesis, resulting in increased cellular permeability.

At the recent SEC meeting for antimicrobial and antiviral held on 22nd August 2024, the expert panel reviewed the proposal for manufacturing and marketing of Ticonazole Vaginal Film 300 mg along with Phase III protocol (Protocol No. HHCL/01-01/24 version 1.0 dated 18/01/2024) before the committee.

After detailed deliberation, the committee opined that the firm should submit adequate rationale/justification for the development of the proposed dosage form in such high strength along with release pattern data of the proposed formulation, adequate toxicity data, anticipated side effects, and supportive clinical evidence of the proposed dosage form to CDSCO for further review by the committee.

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